Belite Bio Inc ADR 2025年年度报告和过渡报告

TABLE OF CONTENTS PARTI ITEM1.Identity of Directors, Senior Management and Advisers6ITEM2.Offer Statistics and Expected Timetable6ITEM3.Key Information6ITEM4.Information On the Company73ITEM4A.Unresolved Staff Comments132ITEM5.Operating And Financial Review and Prospects132ITEM6.Directors, Senior Management and Employees147ITEM7.Major Shareholders and Related Party Transactions159ITEM8.Financial Information161ITEM9.The Offer and Listing162ITEM10.Additional Information162ITEM11.Quantitative And Qualitative Disclosures About Market Risk177ITEM12.Description Of Securities Other Than Equity Securities177PARTIIITEM13.Defaults, Dividend Arrearages and Delinquencies180ITEM14.Material Modifications to The Rights of Security Holders and Use of Proceeds180ITEM15.Controls And Procedures181ITEM16A.Audit Committee Financial Expert181ITEM16B.Code of Ethics182ITEM16C.Principal Accountant Fees and Services182ITEM16D.Exemptions from the Listing Standards for Audit Committees182ITEM16E.Purchases of Equity Securities by the Issuer and Affiliated Purchasers182ITEM16F.Change in Registrant’s Certifying Accountant182ITEM16G.Corporate Governance182ITEM16H.Mine Safety Disclosure182ITEM16I.Disclosure Regarding Foreign Jurisdictions that Prevent Inspections182ITEM16J.Insider Trading Policy183ITEM16K.Cybersecurity183 PartIII 185185185 ITEM17.Financial StatementsITEM18.Financial StatementsITEM19.Exhibits ABOUT THIS ANNUAL REPORT Unless otherwise indicated or the context otherwise requires, references in this annual report on Form20-F(the “Annual Report”) to: ●“ADRs” are to the American depositary receipts that may evidence the ADSs;●“ADSs” are to our American depositary shares, each of which represents one of our ordinary share;●“AUD” are to the legal currency of Australia;●“Belite,” “we,” “us,” “our company,” “Company,” and “our” are to Belite Bio, Inc, a Cayman Islandsexempted company with limited liability and its subsidiaries;●“China” or the “PRC” are to the People’s Republic of China, excluding, for the purposes of this AnnualReport only, Hong Kong, Macau and Taiwan;●“Exchange Act” are to the United States Securities Exchange Act of 1934, as amended;●“EMA” are toEuropean Medicines Agency;●“FDA” are to U.S. Food and Drug Administration;●“IND” are to Investigational New Drug Application;●“Latest Practicable Date” are to March14, 2025;●“SEC” are to the United States Securities and Exchange Commission;●“NMPA” are toNational Medical Products Administration;●“Securities Act” are to the Securities Act of 1933, as amended;●“shares” or “ordinary shares” are to our ordinary shares, par value US$0.0001 per share;●“TGA” are to Therapeutic Goods Administration of Australia;●“US$,” “U.S. dollars,” “$,” and “dollars” are to the legal currency of the United States; and●“U.S. GAAP” are to the generally accepted accounting principles of the United States. Unless otherwise stated, all of our financial information presented in this Annual Report has been prepared inaccordance with U.S. GAAP. Any discrepancies in any table between totals and sums of the amounts listed aredue to rounding. Unless otherwise indicated, or the context otherwise requires, references in this Annual Reportto financial and operational data for a particularyear refer to the fiscalyear of our company ended December31of thatyear. Our reporting currency is the U.S. dollar. The functional currency of the Company’s subsidiaries located inthe United States and Hong Kong is U.S. dollars. The functional currency of the Company’s subsidiary located inAustralia is AUD, the functional currency of the Company’s subsidiary located in China is RMB and thefunctional currency of the Company’s subsidiary located in Taiwan is NTD. Unless otherwise noted, alltranslations from AUD to U.S. dollars and from U.S. dollars to AUD in this Annual Report are made at a rate ofAUD0.6219 to US$1.00, all translations from RMB to U.S. dollars and from U.S. dollars to RMB in this AnnualReport are at the rate of RMB7.1884 to US$1.00 and all translations from NTD to U.S. dollars and from U.S.dollars to NTD in this Annual Report are set the rate of NTD0.0305 to US$1.00. We make no representation thatany AUD or U.S. dollar amounts could have been, or could be, converted into U.S. dollars or AUD, as the casemay be, at any particular rate, or at all. TRADEMARKS, SERVICE MARKS AND TRADE NAMES The “Belite Bio” and “倍亮⽣物” names and logos are our trademarks, trade names and service marks. Theother trademarks, trade names and service marks appearing in this Annual Report are the property of theirrespective owners. We do not intend the use or display of other companies’ trademarks and trade names to implya relationship with, or endorsement or sponsorship of us by, any other companies. Solely for convenience, the trademarks, service marks, logos, copyrights and trade names referred to in thisAnnual Report are without the ® and ™ symbols. Such references are not intended to indicate, in any way, thatwe will not